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Conclusion

The document summarizes the development of a reversed phase HPLC method for determining Cefuroxime sodium using Quality by Design (QbD) principles. Key method components like flow rate, pH, and mobile phase were studied experimentally to understand their interrelationships and optimize preliminary conditions. This QbD approach ensures better product design with fewer development problems, reduces required trials for post-market changes, and allows implementation of new technologies without regulatory scrutiny. The validated method is specific, linear, precise, accurate, robust, and stable for determining Cefuroxime sodium in formulated products.

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Nitin Kashyap
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783 views1 page

Conclusion

The document summarizes the development of a reversed phase HPLC method for determining Cefuroxime sodium using Quality by Design (QbD) principles. Key method components like flow rate, pH, and mobile phase were studied experimentally to understand their interrelationships and optimize preliminary conditions. This QbD approach ensures better product design with fewer development problems, reduces required trials for post-market changes, and allows implementation of new technologies without regulatory scrutiny. The validated method is specific, linear, precise, accurate, robust, and stable for determining Cefuroxime sodium in formulated products.

Uploaded by

Nitin Kashyap
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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CONCLUSION

A reversed phase HPLC method development approach using QbD principles has been
described. The Quality by design project aims to encourage debate about quality in the complete
development of the drug in a systematic manner. This paper has reviewed literature on ideas,
research, policy and practice about quality in determination of Cefuroxime sodium as much
about what we think as what we know. First, the method goals are clarified based on the process
understanding. The experimental design describes the scouting of the key HPLC method
components including flow rate, pH, and mobile phase. The interrelationships are studied and the
preliminary optimized conditions are obtained for each combination. Here a better understanding
of the factors influencing chromatographic separation and greater confidence in the ability of the
methods to meet their intended purposes is done. Moreover, this approach ensures better design
of products with fewer problems in development, reduces the number of trials required for postmarket changes, relies more on process, and understanding and mitigation of risk, allows
implementation of new technology to improve manufacturing without regulatory scrutiny,
enables possible reduction in overall costs of manufacturing resulting in less waste. The
validated method is specific, linear, precise, accurate, robust, rugged, and stable for 24hours and
can be applied for the determination in formulated form. The drug is stable in acidic, thermal,
photolytic and hydrolytic conditions and degrades in basic, oxidative conditions. The potential of
QbD approach for simultaneous development of multiple methods including impurity methods,
assay method, dissolution method, cleaning validation method, etc and thus it should be
implemented.

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